The Food and Drug Administration is pushing back against a Memorandum of Understanding released Tuesday and designed to divide regulatory authority over genetically-engineered animals between USDA and FDA.
The MOU was signed by Ag Secretary Sonny Perdue and Public Health Service Director Adm. Brett Giroir, not by FDA Commissioner Stephen Hahn, who had reportedly refused last week to sign it. After USDA announced the MOU, Hahn tweeted a statement Tuesday saying it does not have the backing of FDA.
"FDA does not support the Memorandum of Understanding" signed by HHS and USDA, he said. "FDA has no intention of abdicating our public health mandate. We’ll continue to stay focused on executing our vital public health mission entrusted to us by the American people."
"FDA remains undeterred in our steadfast commitment to ensure that animal agricultural biotechnology products undergo independent and science and risk-based evaluation by our career experts," Hahn said.
Before Hahn issued his statement, observers were already raising their own questions about the MOU. “Does Admiral Giroir have authority to enter into this MOU on behalf of HHS/FDA?” is one question that needs to be answered, said Ricardo Carvajal, an attorney at Hyman, Phelps & McNamara and formerly associate chief counsel at FDA.
In addition, he said in an email, “Note that much of the arrangement contemplated in the MOU is contingent on rulemaking, which must conform to the underlying statutes as well as the [Administrative Procedure Act]. Also, any rulemaking will take time, and could be subject to a judicial challenge. How will these products be regulated in the interim?”
“I think that the FDA will keep fighting USDA on this,” said Jaydee Hanson, a senior policy analyst at the Center for Food Safety. “We will see what happens after Biden’s folks take charge.”
Essentially, according to the MOU, USDA would have authority over genetically-engineered animals produced for food, while FDA “will preserve its independent review of intentional genomic alterations intended for any purpose other than agricultural use including but not limited to biopharma (other than veterinary biologics) and non-heritable genomic alteration (e.g., gene therapies).”
“FDA will immediately implement a streamlined, risk-based approach to oversight of intentional genomic alterations in animals,” the MOU says, and “FDA and USDA will work on a communication plan to explain FDA's involvement with agriculture amenable species developed using genetic engineering.”
The National Pork Producers Council, which last week accused FDA of “dragging its feet” on the issue, said Tuesday it “applauds” the MOU “giving USDA primary regulatory jurisdiction over the development of gene-edited livestock.”
“NPPC has been calling for this decision for more than three years to ensure that U.S. agriculture maintains its competitive edge globally,” the group said. “We look forward to working with the Biden administration to implement a technology that has the potential to improve animal health, further reduce agriculture’s environmental footprint and improve production efficiency.”
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The Biotechnology Innovation Organization released a brief statement, saying, “At first glance this is a positive step by acknowledging that the regulatory environment for agricultural animal biotechnology innovation deserves attention by multiple agencies. We appreciate this initiative, and BIO looks forward to working with the incoming administration to implement a workable framework for oversight of biotech animals.”
For his part, Perdue noted the need for the MOU and pointed to the possible benefits of genetic engineering.
“Agricultural biotechnology holds tremendous potential to improve animal health, enhance farm productivity, improve nutrition, and even reduce the need for some animal health measures,” Perdue said. “USDA and FDA are committed to working together to foster safe use of this promising technology and encourage innovation.”
USDA issued an Advance Notice of Proposed Rulemaking in December with a “contemplated regulatory framework” dividing responsibilities between the two agencies. The meat industry has been pushing for years to speed up approvals of animals bioengineered for food. In its history, FDA has approved only two such products — Aquabounty’s genetically engineered salmon and Galsafe pigs.
“The USDA has put forward an open and transparent process to establish regulatory certainty surrounding a promising technology,” Wisconsin hog farmer and NPPC President Howard “A.V.” Roth said last week.
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